Regulatory Affairs
Eye on FDA RX for Pharma Industry Communications and Planning
- FDA Adds New AdComm to Address Genetic Metabolic Diseasesby Mark Senak on March 7, 2024 at 4:05 pm
Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). As noted in a recent posting here, … Continue reading →
- What They Said – FDA Press Releases in 2023by Mark Senak on February 8, 2024 at 1:27 pm
Less is more? Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. One might not think that a large agency … Continue reading →
- FDA’s OPDP Sends First Regulatory Letter of the Year Aimed at Rx Drug Promotionby Mark Senak on January 22, 2024 at 7:39 pm
Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional … Continue reading →
- The Year in AdComms – A Look Back at 2023by Mark Senak on December 7, 2023 at 7:15 am
For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Now, with no more … Continue reading →
- FDA’s OPDP Issues Two New Untitled Lettersby Mark Senak on November 10, 2023 at 7:01 am
While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the … Continue reading →
Biotechnology
Biotechnology Industry News | BioSpace RSS Feed for Biotechnology Industry News | BioSpace (Generated by New Sloth)
- PreveCeutical Announces Management Cease Trade Orderon May 3, 2024 at 12:00 am
PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (the "Company" or "PreveCeutical") announces that the Company has missed the filing deadline of April 29, 2024 to file the Company's audited annual financial statements and accompanying management's discussion and analysis
- FDA’s Accelerated Approval of Sarepta DMD Gene Therapy Comes Under Fireon May 3, 2024 at 12:00 am
Ahead of the FDA’s June target action date for Sarepta’s Duchenne muscular dystrophy gene therapy, ICER Chief Medical Officer David Rind blasted the regulator’s accelerated pathway in a JAMA viewpoint article.
- Ocugen to Host Conference Call on Tuesday, May 14 at 8:30 A.M. ET to Discuss Business Updates and First Quarter 2024 Financial Resultson May 3, 2024 at 12:00 am
Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN) today announced that it will host a conference call and live webcast to discuss the Company’s first quarter 2024 financial results and provide a business update at 8:30 a.m. ET on Tuesday, May 14, 2024.
- Awakn Life Sciences Discusses Filing of Financial Statementson May 3, 2024 at 12:00 am
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder (AUD), announces that
- AAVantgarde announces its innovative clinical study design for its lead program in Usher 1Bon May 3, 2024 at 12:00 am
AAVantgarde Bio announced the presentation of the clinical trial design of the Company’s lead program in Usher 1B by the program’s Principal Investigator, Prof. Francesca Simonelli, at the 9th Annual Retinal Cell and Gene Therapy Innovation Summit, being held today in Seattle.
Pharmaceuticals
STAT Pharmalot: Insight and analysis by Ed Silverman Ed Silverman began writing Pharmalot at The Star Ledger of New Jersey in 2007 and it continues to this day at STAT. He joined STAT at its founding in 2015, coming from the Wall Street Journal. He has covered the pharmaceutical industry since 1995. For more insights and analysis, bookmark this page or sign up for his newsletter here.
- STAT+: Up and down the ladder: The latest comings and goingsby Ed Silverman on May 3, 2024 at 2:20 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
- STAT+: Pharmalittle: We’re reading about an Amgen obesity drug, a Senate bill on shortages, and moreby Ed Silverman on May 3, 2024 at 1:23 pm
Amgen will no longer develop an early-stage obesity pill, and will instead focus on a more advanced injectable candidate to compete with Wegovy and Zepbound.
- STAT+: Gilead gets a boost from California court in a case over slow-walking an HIV drugby Ed Silverman on May 2, 2024 at 7:25 pm
The move by the California Supreme Court to review the case is seen as “very important,” according Evercore ISI analyst Umer Raffat.
- STAT+: Pharmalittle: We’re reading about Wegovy and Ozempic sales, rising pharma layoffs, and moreby Ed Silverman on May 2, 2024 at 1:31 pm
Sales of the blockbuster Wegovy obesity treatment more than doubled in the first quarter as Novo Nordisk races to make more of the drug to meet surging demand.
- STAT+: Pharmalittle: We’re reading about FTC fighting ‘junk’ patents, Pfizer direct-to-consumer plans, and moreby Ed Silverman on May 1, 2024 at 1:21 pm
The FTC expanded its campaign against pharmaceutical companies for filing what it calls “junk” patent listings for 20 different brand-name treatments.
Human Resources
HR Dive - Latest News Human Resources and Workforce Management News
- California poultry processors will pay over $5M to resolve overtime, child labor allegationsby Emilie Shumway on May 3, 2024 at 7:28 pm
The U.S. Department of Labor called it “one of the largest wage violation settlements ever reached" for domestic poultry workers.
- Former Google workers file labor board complaint over protest-relating firingsby Lamar Johnson on May 3, 2024 at 7:03 pm
The ex-employees said the tech giant violated their labor rights when firing at least 28 employees for protesting against its cloud services contract with the Israeli government.
- No longer mere ‘infatuation’: Generative AI interest now shapes talent strategy, employers sayby Carolyn Crist on May 3, 2024 at 2:41 pm
Talent limitations are slowing down the ability to scale, leaders said, prompting organizational changes.
- Back to Basics: What is a hostile work environment?by Ginger Christ on May 2, 2024 at 8:43 pm
The burden of proof is always on the employee, a law firm partner told HR Dive.
- Georgia retirement community to shell out $78,000 for age, disability discriminationby Caroline Colvin on May 2, 2024 at 8:23 pm
Along with paying the fired receptionist monetary relief, Covenant Woods must stand up an anti-discrimination training program.